Report shows how the FDA incorporates the two ISO standards in its medical device development policy, how the EU version of the two standards differs in significant ways and how the EU Medical Device Regulation may require further changes in the European standards.

Pharmacopeia, an innovator in the discovery and development of novel small molecule
therapeutics, announced today the formation of a drug discovery, development
and commercialization alliance with Cephalon, Inc., a leading global biopharmaceutical
company. The financial terms of the agreement call for Cephalon to pay Pharmacopeia
an up-front program access fee of $15 million.